Cell culture manufacturing technology is widely used for the production of protein-based therapeutics, such as antibodies, for use in pharmaceutical formulations. Commercial production of protein-based products, such as an antibody product, requires optimization of cell culture parameters in order for the cell to produce enough of the protein product to meet manufacturing demands. However, when cell culture parameters are optimized for improving productivity of the protein product it is also necessary to maintain the desired quality attributes of the product such as the glycosylation profile, aggregate levels, charge heterogeneity, and amino acid sequence integrity (Li, et al., 2010, mAbs., 2(5):466-477).
Bevacizumab, also known as “Avastin®”, is a recombinant humanized monoclonal antibody that binds vascular endothelial growth factor in in vitro and in vivo assay systems (U.S. Pat. No. 7,227,004; U.S. Pat. No. 6,884,879; U.S. Pat. No. 7,060,269; U.S. Pat. No. 7,169,901; U.S. Pat. No. 7,297,334) and is used in the treatment of cancer, where it inhibits tumor growth by Hocking the formation of new blood vessels. Bevacizumab has an approximate molecular weight of 149,000 daltons, is glycosylated, and is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient cell culture medium.
Improved and cost-effective methods of producing bevacizumab, or a fragment thereof, are desirable. Cell culture media comprising components that enable a cell to produce a desired amount of bevacizumab, or a fragment thereof, while maintaining acceptable product quality attributes of bevacizumab, or a fragment thereof, would be beneficial. Cell culture media for use in producing manufacturing-scale amounts of bevacizumab, or a fragment thereof, would be particularly advantageous.